GE Medical Systems Information Technologies Inc: GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetr

Hazard

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

Details from the source

Reason for recall: GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). Distribution: Worldwide distribution. Quantity: 1249 units Lot/code info: no UDI, Serial Number or Sales Order Number: KSA7013962, KSA5646256, KSA5646267, KSA5646268, KSA5646321, KSA5646328, KSA5646242, KSA5646251, KSA5646257, KSA5646284, KSA5646289, KSA5646295, KSA5646297, KSA5646306, KSA5646314, KSA6689326, KSA6689333, KSA6689378, KSA7162600, KSA7162603, KSA7162619, KSA7162631, KSA7769614, KSA6017390, KSA6569811, KSA6569814, KSA6569816, KSA6569853, KSA6569856, KSA6569866, KSA6569875, KSA6569879, KSA6569896, KSA7162612, KSA7162623, KSA7162662, KSA6409156, KSA6409176, KSA6409177, KSA6409181, KSA6420012, KSA6420057, KSA6420088, KSA6420106, KSA7013897, KSA5646292, KSA6409244, KSA7162605, KSA6808884, KSA7304364, KSA7304449, KSA7304452, KSA6590164, KSA7304435, KSA6954216, KSA6954221, KSA6626645, KSA6689380, KSA6808843, KSA6808843, KSA6808873, KSA6808874, KSA6808897, KSA6808897, KSA6623262, KSA6945167, KSA6017455, KSA7096908, KSA7096928, KSA7096932, KSA7096935, KSA7096940, KSA7096941, KSA7096946, KSA7096959, KSA7096971, KSA7096976, KSA7096985, KSA7096986, KSA7096994, KSA7550169, KSA7304426, KSA6017413, KSA6420074, KSA7442867, KSA7520473, KSA6945379, KSA7495811, KSA7495812, KSA7495828, KSA7495833, KSA6623187, KSA6623188, KSA6623208, KSA6623241, KSA6623249, KSA6623265, KSA6623273, KSA6623282, KSA6664042, KSA6017434, KSA6017505, KSA6664062, KSA6664066, KSA7162592, KSA5646252, KSA7304361, KSA7304418, KSA6689310, KSA6689342, KSA7391408, KSA7391483, KSA7442814, KSA7442876, KSA5646246, KSA6017327, KSA6017337, KSA6017411, KSA6017418, KSA6017452, KSA7574793, KSA

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.